inforMED
MalfunctionCEO

PHOS2 PHOSPHATE (INORGANIC) VER.2

Received Mar 13, 2018 · Event occurred Feb 10, 2018

Report 1823260-2018-00806 · MDR key 7334077

Device

Generic name

Phosphomolybdate (colorimetric), Inorganic Phosphorus

Manufacturer

Roche Diagnostics

Model number

NA

Catalog number

05171377190

Lot number

282314

Product problems

  • High Test Results
  • High Test Results

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

(B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR MULTIPLE PATIENTS TESTED FOR PHOS2 PHOSPHATE (INORGANIC) VER.2 (PHOS2) ON A COBAS 8000 C 702 MODULE THAT STARTED ON (B)(6) 2018. DATA WAS PROVIDED FOR 163 PATIENT SAMPLES. THE PHOS2 RESULTS FOR 46 PATIENTS WERE DISCREPANT. THE INITIAL RESULTS HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. FOLLOWING REPEAT TESTING, CLINICIANS WERE CONTACTED WITH THE AMENDED RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE C702 MODULE SERIAL NUMBER WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) HAD VISITED THE CUSTOMER SITE ON 05-FEB-2018 AND ALL REAGENT AND SAMPLE PROBES ALONG WITH THE GEAR PUMP HEAD WERE REPLACED. ON (B)(6) IT WAS DISCOVERED THAT THE ION BLOWER HAD BEEN TURNED OFF. THIS WAS TURNED BACK ON. THE CUSTOMER THINKS THE ISSUE WAS DUE TO A PARTICULAR REAGENT LOT. THE CUSTOMER STATED THAT EVERY REAGENT PACK THAT SHOWED ISSUES WAS FROM A DELIVERY RECEIVED ON (B)(6) 2018 AND PUT IN USE ON (B)(6) 2018. ALL CALIBRATIONS FROM 30-JAN-2018 THROUGH 22-FEB-2018 WERE DONE WITH THE REAGENT LOT IN QUESTION (282314). CALIBRATION ERRORS WERE OBSERVED ON (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2018. ALL OTHER CALIBRATIONS SEEMED OK.

Additional Manufacturer Narrative

THE FSE CHECKED AND ADJUSTED THE GEAR HEAD PUMP AND THE CELL WASH LEVELS FOR THE CUVETTES. ALL PROBES WERE CHECKED AND ADJUSTED WHEN APPROPRIATE. DURING TESTING WITH THE REAGENT LOT IN QUESTION (282314), THE RESULTS SHOWED THERE WAS POTENTIAL CARRYOVER FROM BOTH REAGENT PROBES ON CAROUSEL B AND POTENTIAL CARRYOVER FROM ONE REAGENT PROBE ON CAROUSEL A. THE PROBES WERE REPLACED, HOWEVER THE POTENTIAL CARRYOVER ISSUE WAS NOT RESOLVED FOR ONE PROBE ON CAROUSEL B. THIS PROBE WAS CHECKED FOR PROPER ALIGNMENT AND IT REQUIRED SOME EXTRA ADJUSTMENT SUGGESTING THE ORIGINAL PROBE MAY HAVE BEEN BENT. AFTER RETESTING, THERE WAS NO LONGER ANY POTENTIAL CARRYOVER. THE INVESTIGATION DETERMINED THAT THE PROBE ISSUE FOUND BY THE FSE WAS THE ROOT CAUSE OF THE EVENT.